Coronary Artery Disease Clinical Trial
Official title:
Cloud-based ECG Monitoring and Healthcare Model Building on the Population With Coronary Artery Revascularization
Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the
golden treatments for stable coronary artery disease (CAD) combined with heart failure (HF).
The goal of treating HF patients is to prevent repeated hospitalizations and improve
peri-operative survival; clinically, although routines including beta-receptor inhibitors,
angiotensin-converting enzyme (ACE) inhibitors, and mineralocorticoids have been shown
beneficial for the prognosis, for patients with severely low left ventricular ejection rate,
hypotension, and pulmonary disease, the introduction of these drugs in the early
postoperative period should still be cautious and may need to be adjusted with related
cardiovascular function parameters. Patients with low cardiac output syndrome, ventricular
arrhythmia, or hemodynamic instability should be suspected of the failure of bypass grafts if
accompanied by changes in the electrocardiogram (EKG) and an increase in myocardial enzymes.
Intervention should be carried out as soon as possible after angiography detects graft
failure to limit the occurrence of large-scale myocardial injury and prevent the development
of severe myocardial failure.
This study is start on June 1 2020. And will include 400 patients who have just undergone PCI
and 300 CABG patients who diagnosis of stable coronary artery disease. We will register their
medical history, medications, and routine medical examinations within one year, and perform
tests such as phonocardiography (Audiocor). They will be worn and measured daily at home
after discharge. The data of the electrocardiogram and the PPG bracelet will be registered
with their continuous daily values. All subjects tracked the occurrence of adverse medical
events within one year after discharge from the hospital. Based on the home-based remote
personal care model for patients with CABG, a risk prediction model for heart failure and
vascular restenosis was established to effectively reduce medical treatment, adverse events,
and medical expenditure.
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive
research. This study is start on June 1 2020. And will include 400 patients who have just
undergone PCI and 300 CABG patients who diagnosis of stable coronary artery disease. And
random allocation 350 experimental group (Non-invasive Wearable Device) and 350 control group
(routine medical).
Ask whether the patients who meet the exclusion criteria are willing to participate in the
screening (Screening), if they are willing to join and sign the consent of the subject, and
after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge
from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4
weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The
results of these two tests and other basic information of the patient, including Demography,
Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association
recommended routine test results of high-risk patients, including Blood Chemistry Panel,
NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of
the logged-in subjects on the paper case report form. The CRF only displays the study number,
and no subject is available. In addition to the examination of each return visit, the
subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day.
After the discharge, the ECG was measured every morning and evening, and their personal
activity and sleep were collected. Relevant information. After the subject was discharged
from the hospital, the subject tracked the date of all adverse events due to cardiovascular
disease within one year, including: heart failure, restenosis due to blood vessel, and
non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the
occurrence of death.
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